Validation of an electrochemical sensor based on gold nanoparticles as a point-of-care test for quantitative determination of glycated hemoglobin

Monitoring the level of glycated hemoglobin (HbA1c) has become the gold standard measure for diabetes mellitus (DM) diagnosis and control, used in conjunction with fasting blood glucose (FBG) and oral glucose tolerance test. This study aimed to investigate the applicability of a newly developed nanoparticle-based electrochemical sensor—multiwalled nanotubes incorporated with gold nanoparticles (POCT-HbA1c(MWCNTs/AuNPs))—used as a routine point-of-care test (POCT) for detection of HbA1c for the diagnosis of DM. Finger-prick and venous blood samples were collected from 108 DM and 98 non-DM subjects to determine HbA1c and total hemoglobin by POCT-HbA1c(MWCNTs/AuNPs) compared with the standard HPLC method. The performance of the POCT-HbA1c(MWCNTs/AuNPs) was evaluated using the standard cut-off HbA1c level of >6.5%. The test’s sensitivity, specificity, positive predictive value, and negative predictive value were 100.00%, 90.32%, 87.23%, and 100.00%, respectively. The probability of DM diagnosis in a subject with HbA1c >6.5% (positive predictive value) was 87.23% (82/94). The accuracy of the POCT-HbA1c(MWCNTs/AuNPs) was 94.18%, with a %DMV (deviation from the mean value) of 0.25%. The results indicate satisfactory assay performance and applicability of the POCT-HbA1c(MWCNTs/AuNPs) for diagnosis of DM using the cut-off criteria of HbA1c >6.5.